Universities Allied for Essential Medicines: Can a Student Group Influence University Technology Licensing Policies?
by: Stephen Moyer, Associate Editor, MTTLR
Image Biotic lensbaby by Sparky.
Used under a Creative Commons BY-NC 2.0 license.
The contributions of research universities to worldwide scientific progress have traditionally been focused on basic scientific discoveries, rather than efforts to ensure that their scientific discoveries actually reach people throughout the world.. Universities Allied for Essential Medicines (UAEM)1 is a non-profit organization that works with faculty and student groups to help ensure the availability of essential medicines in poor countries.2 Among other activities, UAEM hopes to persuade universities to commit to the principle that when they license university-developed medical-related technologies to private companies, a condition of the license will be that the private company agree to make medicines that are created using the university-developed technology available to the developing world at the lowest possible cost.3
The history of this movement stretches back to 2001 when Yale University students became aware that an important anti-HIV medication, stavudine (also known as d4T), that had been developed at Yale and licensed by Yale to the pharmaceutical company Bristol-Myers Squibb (BMS), was not available to many HIV-positive patients in South Africa because of its high cost. 4 The high cost of the drug stemmed at least in part from the fact that it was under patent protection in South Africa.5 After Yale students and others petitioned Yale and BMS not to enforce the patent in South Africa, BMS ultimately agreed to the proposal, which thereby enabled the sale of much cheaper generic versions of the drug. 6
From this experience (which received a substantial amount of national publicity 7) and the understanding that universities are a major source of scientific discoveries that lead to the development of new medicines,8 students at Yale and other universities became convinced of the need for a national organization that would seek to persuade universities to ensure that university-developed scientific advances do not fail to reach people in developing countries because of intellectual property protection of the drugs.
The general proposition that drug companies should make medicines available to low income countries at the lowest possible cost is easy to support on a humanitarian level, but the proposition may appear less realistic on a practical level: pharmaceutical research and development are costly, as is the manufacture of drugs. Patent protection for new drugs is understood to be integral to the ability of pharmaceutical companies to generate income, recoup their costs, and make drug development profitable to fund on-going research. UAEM argrees that patent protection of new drugs is indeed necessary and appropriate in developed countries, but argues that patent protection of new drugs in developing countries can be harmful. First-world prices are prohibitive for most third-world consumers – drug companies do not realize significant amounts of income from poorer countries, precisely because the high prices result in comparatively small amounts of drugs sold.9 Therefore, UAEM argues that universities and drug companies can make their drugs available to developing countries at low cost, realize higher volumes of sales, and still generate nearly the same profits as they would by selling higher-cost versions of the drugs in these countries. 10
In 2006, UAEM drafted a concise document that captures the major goals of the organization, the “Philadelphia Consensus Statement” (PCS).11 The PCS is a collection of recommendations that UAEM urges universities to adopt, the key recommendations being that, in addition to ensuring that university-developed technologies are available to developing countries, universities should also promote research into diseases that primarily affect developing countries, and that universities should measure their success at research based on its “impact on human welfare”, rather than just its scientific or income-producing value.12 UAEM obtained support of many prominent individuals and organizations for the PCS, with a list of initial signatories to the PCS that includes multiple Nobel prize winners, university leaders, and international organizations.13
UAEM has held national meetings every year since 2005 to further develop and coordinate its efforts; this year’s meeting will be held at the University of California-Berkeley, on October 17-19, 2008.14
While most people support UAEM's mission, some are concerned that UAEM’s efforts regarding university technology licensing may be ineffective or even counter-productive towards the overall objective of increasing access to medicines.
One concern is that it frequently may not be possible for a university to only license technologies to companies that are willing to make drugs available to developing countries at low cost; it can be difficult for universities to find any companies interested in licensing their technologies. The more restrictions the university puts on licensing agreements, these critics argue, the more difficult it may be for the university to find a party interested in licensing the university technology. 15
Another concern is that if companies agree to allow lower-priced generic versions of drugs to be produced in developing countries while those drugs are still patent-protected in developed countries, the generic drugs could be smuggled into developed countries, and severely damage drug sales there16. UAEM counters that there is not evidence that this type of transfer happens on a large scale, and that drugs can be marked with identifying source information, in order to minimize this problem. 17
Access to medicine remains a major problem worldwide – the World Health Organization estimates that about 10 million people die every year because they do not have access to existing medicines.18 Universities play a major role in developing new medicines, and it is consistent with the mission of universities to ensure that medicines developed on their campuses reach as much of the world’s population as possible. While it remains to be seen what impact UAEM’s efforts will have on universities’ technology licensing policies in the long term, UAEM has brought attention to the important connection between university research and global access to medicine.
1. Universities Allied for Essential Medicines
2. Universities Allied for Essential Medicines, About Us.
3. See Ethan Guillen and Rachel Kiddell-Monroe, Research Universities Must Act, Boston Globe, Oct 3, 2007.
4. Daryl Lindsey, Amy and Goliath, Salon.com, May 1, 2001.
5. See id.
6. Amy Kapczynksi, E. Tyler Crone, and Michael Merson, Global Health and University Patents 301 Science 1629,(2003).
7. See, e.g. Donald McNeil, Yale Pressed to Help Cut Drug Costs in Africa, New York Times, Mar. 12, 2001; Abigail Zuger, A Molecular Offspring, Off to Join the AIDS Wars, New York Times, Mar. 20, 2001.
8. Universities, Not Companies, Drive Biotech Advancement, UCSF Today, May 8, 2007.
9. Samantha Chaifetz, et. al. Closing the access gap for health innovations: an open licensing proposal for universities, 3 Globalization and Health 1, (2007).
10 David Chokshi Improving Access to Medicines in Poor Countries: The Role of Universities, 3 PLoS Medicine 0723, 0725 (2006).
11. Universities Allied for Essential Medicines, Philadelphia Consensus Statement, (2006).
12. Id.
13. Universities Allied for Essential Medicines, Philadelphia Consensus Statement – Initial Signatories.
14. Universities Allied for Essential Medicine, 2008 Conference Registration.
15. Erika Check, Universities urged to do more for poor nations, 444 Nature 412 (2006).
16. David Chokshi,Improving Access at 0725.
17. Id.
18. World Health Organization, Equitable access to essential medicines: a framework for collective action, WHO Policy Perspectives on Medicines, March, 2004.
Introduction
Image Biotic lensbaby by Sparky.Used under a Creative Commons BY-NC 2.0 license.
The contributions of research universities to worldwide scientific progress have traditionally been focused on basic scientific discoveries, rather than efforts to ensure that their scientific discoveries actually reach people throughout the world.. Universities Allied for Essential Medicines (UAEM)1 is a non-profit organization that works with faculty and student groups to help ensure the availability of essential medicines in poor countries.2 Among other activities, UAEM hopes to persuade universities to commit to the principle that when they license university-developed medical-related technologies to private companies, a condition of the license will be that the private company agree to make medicines that are created using the university-developed technology available to the developing world at the lowest possible cost.3
The history of this movement stretches back to 2001 when Yale University students became aware that an important anti-HIV medication, stavudine (also known as d4T), that had been developed at Yale and licensed by Yale to the pharmaceutical company Bristol-Myers Squibb (BMS), was not available to many HIV-positive patients in South Africa because of its high cost. 4 The high cost of the drug stemmed at least in part from the fact that it was under patent protection in South Africa.5 After Yale students and others petitioned Yale and BMS not to enforce the patent in South Africa, BMS ultimately agreed to the proposal, which thereby enabled the sale of much cheaper generic versions of the drug. 6
From this experience (which received a substantial amount of national publicity 7) and the understanding that universities are a major source of scientific discoveries that lead to the development of new medicines,8 students at Yale and other universities became convinced of the need for a national organization that would seek to persuade universities to ensure that university-developed scientific advances do not fail to reach people in developing countries because of intellectual property protection of the drugs.
UAEM’s Argument
The general proposition that drug companies should make medicines available to low income countries at the lowest possible cost is easy to support on a humanitarian level, but the proposition may appear less realistic on a practical level: pharmaceutical research and development are costly, as is the manufacture of drugs. Patent protection for new drugs is understood to be integral to the ability of pharmaceutical companies to generate income, recoup their costs, and make drug development profitable to fund on-going research. UAEM argrees that patent protection of new drugs is indeed necessary and appropriate in developed countries, but argues that patent protection of new drugs in developing countries can be harmful. First-world prices are prohibitive for most third-world consumers – drug companies do not realize significant amounts of income from poorer countries, precisely because the high prices result in comparatively small amounts of drugs sold.9 Therefore, UAEM argues that universities and drug companies can make their drugs available to developing countries at low cost, realize higher volumes of sales, and still generate nearly the same profits as they would by selling higher-cost versions of the drugs in these countries. 10
Philadelphia Consensus Statement and Annual Meetings
In 2006, UAEM drafted a concise document that captures the major goals of the organization, the “Philadelphia Consensus Statement” (PCS).11 The PCS is a collection of recommendations that UAEM urges universities to adopt, the key recommendations being that, in addition to ensuring that university-developed technologies are available to developing countries, universities should also promote research into diseases that primarily affect developing countries, and that universities should measure their success at research based on its “impact on human welfare”, rather than just its scientific or income-producing value.12 UAEM obtained support of many prominent individuals and organizations for the PCS, with a list of initial signatories to the PCS that includes multiple Nobel prize winners, university leaders, and international organizations.13
UAEM has held national meetings every year since 2005 to further develop and coordinate its efforts; this year’s meeting will be held at the University of California-Berkeley, on October 17-19, 2008.14
Some Criticisms of UAEM’s Approach
While most people support UAEM's mission, some are concerned that UAEM’s efforts regarding university technology licensing may be ineffective or even counter-productive towards the overall objective of increasing access to medicines.
One concern is that it frequently may not be possible for a university to only license technologies to companies that are willing to make drugs available to developing countries at low cost; it can be difficult for universities to find any companies interested in licensing their technologies. The more restrictions the university puts on licensing agreements, these critics argue, the more difficult it may be for the university to find a party interested in licensing the university technology. 15
Another concern is that if companies agree to allow lower-priced generic versions of drugs to be produced in developing countries while those drugs are still patent-protected in developed countries, the generic drugs could be smuggled into developed countries, and severely damage drug sales there16. UAEM counters that there is not evidence that this type of transfer happens on a large scale, and that drugs can be marked with identifying source information, in order to minimize this problem. 17
Conclusion
Access to medicine remains a major problem worldwide – the World Health Organization estimates that about 10 million people die every year because they do not have access to existing medicines.18 Universities play a major role in developing new medicines, and it is consistent with the mission of universities to ensure that medicines developed on their campuses reach as much of the world’s population as possible. While it remains to be seen what impact UAEM’s efforts will have on universities’ technology licensing policies in the long term, UAEM has brought attention to the important connection between university research and global access to medicine.
1. Universities Allied for Essential Medicines
2. Universities Allied for Essential Medicines, About Us.
3. See Ethan Guillen and Rachel Kiddell-Monroe, Research Universities Must Act, Boston Globe, Oct 3, 2007.
4. Daryl Lindsey, Amy and Goliath, Salon.com, May 1, 2001.
5. See id.
6. Amy Kapczynksi, E. Tyler Crone, and Michael Merson, Global Health and University Patents 301 Science 1629,(2003).
7. See, e.g. Donald McNeil, Yale Pressed to Help Cut Drug Costs in Africa, New York Times, Mar. 12, 2001; Abigail Zuger, A Molecular Offspring, Off to Join the AIDS Wars, New York Times, Mar. 20, 2001.
8. Universities, Not Companies, Drive Biotech Advancement, UCSF Today, May 8, 2007.
9. Samantha Chaifetz, et. al. Closing the access gap for health innovations: an open licensing proposal for universities, 3 Globalization and Health 1, (2007).
10 David Chokshi Improving Access to Medicines in Poor Countries: The Role of Universities, 3 PLoS Medicine 0723, 0725 (2006).
11. Universities Allied for Essential Medicines, Philadelphia Consensus Statement, (2006).
12. Id.
13. Universities Allied for Essential Medicines, Philadelphia Consensus Statement – Initial Signatories.
14. Universities Allied for Essential Medicine, 2008 Conference Registration.
15. Erika Check, Universities urged to do more for poor nations, 444 Nature 412 (2006).
16. David Chokshi,Improving Access at 0725.
17. Id.
18. World Health Organization, Equitable access to essential medicines: a framework for collective action, WHO Policy Perspectives on Medicines, March, 2004.
Labels: international, patent, pharmaceutical
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